Medical implants manufacturer has for years relied on Ukrainian suppliers for significant amount of human tissue

September 7, 2012

One of the biggest players in the global trade in human tissue has suspended its partnership with suppliers in Ukraine, where authorities have carried out multiple investigations over allegations of illegal tissue recovery.

RTI Biologics, a Florida-based manufacturer of medical implants made from skin, bone and other human parts, "made a decision to voluntarily suspend import of tissues from Ukrainian institutions," the company said in a statement[3] Thursday.

Congressional staffers and the Pentagon announced this week they were reviewing contracts[4] the government holds with RTI and its German subsidiary Tutogen Medical. The International Consortium of Investigative Journalists reported[5] in July on RTI's relationship with morgues under investigation for allegedly forging documents or bullying families into signing donor consent forms.

"We comply with comprehensive regulations, both from U.S. regulatory authorities and those of other countries, that govern each and every activity performed by tissue banks," RTI said.

Ukrainian law, like U.S. law, requires donors or their loved ones give express consent before tissue can be recovered.

The trade in human parts is a billion-dollar industry that is growing and changing so rapidly, legislation has a hard time keeping pace. It is illegal in most countries to buy or sell human parts, but companies can charge fees for handling the tissue. RTI is a publicly-traded company that warns its stockholders, "the supply of human tissue has at times limited our growth, and may not be sufficient to meet our future needs."

RTI obtains tissue from more than 30 procurement agencies in the United States as well as in places such as Ukraine. The company supplies hospitals in more than 30 countries and in all fifty states. Records show the company has offered Ukrainian tissue to hospitals in New York.

German officials had planned a September inspection of 10 Ukrainian morgues that supply Tutogen, according to Ines Schantz, a spokeswoman for the Upper Bavarian government in Germany. But the company withdrew its licenses to import tissue from Ukraine into Germany on August 20.

The German government subsequently cancelled its plans to inspect the foreign tissue agencies. "After the removal of all the institutes from the import license, there was no legal basis any longer to perform the planned inspection," Schantz said.

She said German authorities continue to investigate human tissues already imported from the Ukraine.

ICIJ's eight-month investigation[6] revealed that Tutogen, which was acquired by RTI in early 2008, has for years relied on its Ukrainian suppliers for a significant amount of human tissue in spite of concerns raised within the company more than a decade ago and a series of subsequent investigations.